Market Trends for Biosimilars
Biologics are a prominent and expanding future of the pharmaceutical industry. Their important uses include the treatment of diseases like multiple sclerosis, cancer, rheumatoid arthritis and more. Biologics include monoclonal antibodies, growth factors, recombinant hormones, and blood products. They are one of the popular drugs worldwide but the major flaw has been its unreasonable cost, which makes it unaffordable to many patients, most particularly in developing countries, where the concept of health insurance is at early stages.
In a positive light, once the developer company loses its patent protection and intellectual rights, it opens up a wide range of opportunities in manufacturing similar products at an affordable price. This led to the development of biosimilar drugs that are fabricated using a living system, making sure that they are similar to the reference biologics, achieving a nearly identical therapeutic effect.
Biosimilars and their impact on the healthcare industry:
As discussed, Biosimilar is a biologic product, which is very identical to Food and Drug Administration (FDA) – approved biological product and has no clinically substantial differences in terms of the effectiveness and safety of the reference product. But biosimilars are not exactly the same as the reference product due to the complex structure, which may be affected during the post-translational modifications and minor alteration in sequences.
It is popularly believed that biosimilars will have a guaranteed effect on lowering drug pricing. Physicians and health-care experts are optimistic that the biosimilars market has a possibility of reducing the cost of biologics, leading to greater patient access to these drugs and ultimately leading to the reduction of the overall cost of treatment.
How can a biosimilar receive an FDA approval?
According to the FDA, a biosimilar can only be approved if it has the clinical effects, dosage, and route of administration as the reference biologics. The indications for FDA approval of a biosimilar do not always have to include all the terms of the reference product. There can be a difference according to the new biosimilar sponsor’s application and to the extent to which the clinical trial information is provided. Manufacturers seeking the biosimilar approval from the FDA must file a 351(k) application. Over the past few years, the FDA has been working on issuing and revising documents outlining the generic approach used in determining similarity to the reference biologics. The approach continues to evolve over the years.
Biosimilar regulations in India: Current scenario
Meanwhile, India is known for its flourishing biosimilar market in comparison to the other players and due to this, pharmaceutical companies in India have risen to be known as the thriving global biosimilars market leaders. The very first biosimilar drug developed and marketed in India was way back in the year 2000 for hepatitis B, although no strict regulatory policy was available at that time for the biosimilar manufacturing in India. Currently, there are a large number of growing pharmaceutical companies, which are engaged in the development and manufacturing of biosimilars. One of the leading Biotech companies in the Biosimilar game is Lazuline Biotech, in developing and marketing its flagship product Recombinant Human Serum Albumin (rHSA). This particular type of rHSA is a Pichia pastoris variant. rHSA is a genetically engineered, animal component-free and serum-free product that is structurally equivalent to native human serum albumin.
To keep the companies in track and updated about the concerns associated with the manufacturing of biosimilars, Central Drugs Standard Control Organization (CDSCO) in collaboration with the Department of Biotechnology (DBT) came up with “Guidelines on Similar Biologics, Regulatory Requirements for Marketing Authorization in India” in the year 2012 and revised it again lately, in 2016.
In the near future, it should be acknowledged that several companies are said to have patents expire which has the potential to open a window for whole new opportunities for the development of biosimilars. The global market for biosimilars is expected to rapidly rise by US$10 billion and an opportunity for many potential companies to enter this promising sector. Although the biosimilar market still has more potential for growth in the United States, India is a player to be reckoned with in the world of developing biosimilars. The biosimilar market in India was approximately US$300 million in 2015. The domestic sales are close to US$250 million, with an increasing compound annual growth rate of 14%. The Indian biosimilar exporting market is believed to stand at an impressive amount of US$51 million. India is potentially set to become a leading global player in the biosimilars market.
What does the future hold?
Biosimilars have a bright future in holding the promise in improving a patient’s accessibility for a wide range of diseases by considerably reducing the treatment cost. Since the first biosimilar hit the market in 1996, the manufacturing and marketing of biosimilars have witnessed extraordinary growth. Every year, various biosimilars are being granted by the regulatory agencies for the treatment of many deadly diseases and the improvisation of technical processes. We at Lazuline Biotech look forward to taking ahead of the league and collaborating with potential leaders across the globe to set a benchmark. Our flagship product recombinant human serum albumin (rHSA) being animal component-free and highly pure offers an opportunity to help reach innovation from bench to bedside